Every year, roughly 320 patients aged 60 and older with a broken elbow will be randomly assigned to either have the bone fixed with plates and screws or to have the entire joint replaced with an artificial elbow. This matters because there is no clear evidence which surgery works better for older patients. Currently, most surgeons fix the bone, but small studies and registry data suggest replacement may offer faster, better recovery. Without a large, definitive trial, practice remains inconsistent and patients may receive suboptimal treatment. If the FOREST trial shows that elbow replacement leads to better function and fewer complications, it could shift surgical practice across the NHS. That would mean more older patients regaining arm use sooner, fewer repeat operations, and more efficient use of NHS resources in trauma care. If fixation proves superior, the NHS can avoid unnecessary joint replacements. Either way, the trial will produce clear, cost-effectiveness data to guide surgeons and commissioners, reducing unwarranted variation in care.
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RESEARCH QUESTION What is the clinical and cost effectiveness of treating distal humerus fractures in adults aged 60 years and older with elbow replacement (ER) compared to fracture fixation surgery using plates and screws? BACKGROUND Distal humerus fractures are an injury affecting both older and younger patients with an increasing prevalence, particularly in older patients. In older patients it is not clear if fixation of the bone or ER gives better functional outcomes. Currently the majority of patients undergo fixation, but registry data indicates that replacement is increasingly utilised due to the potential superior functional results reported and a single small trial suggesting superior functional results for replacement in this group. PRIMARY OBJECTIVE To compare upper limb specific function between ER and open reduction in fracture (ORIF) at 4 months after treatment. SECONDARY OBJECTIVES To compare at 4 and 12 months: 1. Upper limb specific function 2. Health-related Quality of Life 3. Healthcare resource use and comparative cost effectiveness 4. Patients recovery of function and additionallyacross all available follow up (average 2.5 years) : 5. Establish the need for re-intervention 6. Compare complication and revision rates METHODS Design: A pragmatic prospective parallel two group superiority RCT unblinded intervention, blinded for outcomes with an internal pilot phase of 12 months. Setting: 20 Acute Care NHS Trusts which are part of Getting It Right First Time (GIRFT)- or approved elbow arthroplasty hubs Population: Patients presenting with a fracture of the distal humerus Inclusion criteria: • Aged = 60 years • Suitable for surgery with either ER or ORIF Exclusion criteria • Open or pathological fractures • Injury > 21 days • Multiple fractures in same arm precluding one treatment option Intervention: Elbow replacement Comparator: Open reduction internal fixation with plate and screws Primary Outcome: DASH score at 4 months post-surgery Secondary Outcomes at 4 & 12 months • Oxford Elbow Score • EQ-5D-5L • Complications and re-operation rates At 12 months • DASH • Cumulative complications, reoperation and revision rates at all available follow-up (average 2.5 years) • Length of hospital stay (days), discharge destination, days in usual residence, return to driving and work Sample Size: 320 participants (160 per arm), recruited over 37 months from a minimum of 20 sites to enable detection of an 8 point between-group difference in the DASH at 4 months post intervention. Resource Cost Factors • Hospital costs of treatment and intervention • Health, Social Care, Personal and Societal Costs at 4 and 12 months Timeline: • M0-9: Setup, ethical and data linkage approvals • M10-47: Recruitment of sites and participants • M14-59: Follow up data collection, site close down • M59: Reintervention data collected • M60-62: Data clean • M63-68: Analysis ANTICIPATED IMPACT AND DISSEMINATION The trial aims to improve clinical care for patients with distal humeral fractures, reduce variation in practice and ensure appropriate allocation of NHS resources in this trauma care setting. We will work with our PAG to produce patient facing trial summaries as short information leaflets and infographics that are accessible, understandable and readily available. We will ensure the key findings of the trial are reported in open access journals to maximise impact.
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